Tavaborole topical solution recalled from three lots because of discoloration
Viona Pharmaceuticals is recalling 13,080 bottles of Tavaborole Topical Solution 5% across three lots because of discoloration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a product appearance defect: the record cites discoloration only, with no hazard or reported harm.
Plain-English summary
Tavaborole Topical Solution 5%, in 10 mL bottles, manufactured by Zydus Lifesciences in Ahmedabad, India and distributed by Viona Pharmaceuticals of Cranford, New Jersey, is being recalled for discoloration.
The recall covers 13,080 bottles from lots T400819 and T400820, expiring 30 April 2026, and lot T401969, expiring 30 September 2026, carrying NDC 72578-102-04. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the discoloration without describing a health consequence, and reports no injuries.
Patients holding an affected lot should contact their pharmacy or prescriber about a replacement.
The recalled product
- Product
- TAVABOROLE (TAVABOROLE)
- Brand
- TAVABOROLE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Category
- Drug — Topical antifungal
- Hazard
- discoloration
- product-appearance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot#: T400819
- T400820
- Exp 4/30/26
- T401969
- Exp 9/30/26
Distribution
Distributed nationwide across the United States.
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